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NCT01151098 · ClinicalTrials.gov registry record · Phase 3
Safety of Buprenorphine Transdermal Systems in Subjects With Chronic Nonmalignant Pain - a 28-week Extension Study
A Phase 3 study, sponsored by Purdue Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 189
- Enrollment target
NCT01151098: Completed Phase 3 study, sponsored by Purdue Pharma.
NCT01151098 is a Phase 3 study that has completed, run by Purdue Pharma. The registered enrollment target is 189 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (76% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01151098, a Phase 3 study, has completed, sponsored by Purdue Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 189 participants
- Enrollment target
Study Summary
The objective of this study was to evaluate the long-term safety and tolerability of 7-day BTDS in a 28-week open-label extension phase in subjects with chronic nonmalignant pain syndromes whose pain had been previously controlled by oral opioid combination therapy.
Primary Outcome
Safety was assessed using reports of all new adverse events (AEs) that occurred after the first application of a patch during the extension phase were recorded.
Interventions
- DRUG Buprenorphine transdermal patch
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 189 participants |
| Start Date | 2001-04 |
| Est. Completion | 2002-02 |
| Phase | Phase 3 |
What the finished NCT01151098 record still lists
NCT01151098 is an interventional study that assigns participants to a tested intervention. The registered 189 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (76% lower).
The record links to 0 conditions, and to 1 intervention - of which Buprenorphine transdermal patch is the first listed.
NCT01151098 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01151098 about?
NCT01151098 is a clinical study titled "Safety of Buprenorphine Transdermal Systems in Subjects With Chronic Nonmalignant Pain - a 28-week Extension Study". The objective of this study was to evaluate the long-term safety and tolerability of 7-day BTDS in a 28-week open-label extension phase in subjects with chronic nonmalignant pain syndromes whose pain had been previously controlled by oral opioid combination therapy.
What is the current status of trial NCT01151098?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 189 participants. The study started on 2001-04. Estimated completion is 2002-02.
What interventions are being tested in trial NCT01151098?
The interventions under investigation include: Buprenorphine transdermal patch (DRUG).
Who is sponsoring clinical trial NCT01151098?
This trial is sponsored by Purdue Pharma, which has 54 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01151098's enrollment target sits among peer trials
189 1408th of 2000 higher than 593 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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